Dermatitis is defined as an inflammation of the skin. Stedman""s Medical Dictionary, 25th edition, pp.418-419, Williams and Wilkins, Baltimore. 1990. Among the types of dermatitis are contact dermatitis, atopic dermatitis (i.e., eczema), psoriasis, and seborrheic dermatitis. Stedman""s Medical Dictionary, 25th edition, pp.418-419, Williams and Wilkins, Baltimore. 1990.
Contact dermatitis is an altered state of skin reactivity induced by exposure to an external agent. Substances that produce this condition can be an irritant or an allergen. Irritants cause direct tissue damage while allergens induce an immunologic reaction that causes inflammation and tissue damage. With the enormous number of artificial compounds in the human environment today that can be irritants or allergens, contact dermatitis is becoming more common. Over 2800 substances have been identified as contact allergens. Contact dermatitis is responsible for approximately 5.7 million physician visits per year in the U.S.
The term eczema is used to describe all kinds of red, blistering, oozing, scaly, brownish, and itching skin conditions. Examples include seborrheic eczema, nummular eczema, and allergic contact eczema. Eczema is also sometimes used to refer specifically to atopic dermatitis, which is a group of allergic or associated diseases that usually affect several members of a family. These families usually have allergies such as hay fever and asthma. Atopic dermatitis is very common throughout the world. Atopic dermatitis is typically recognized by an itching rash, along with a family history of allergies. It affects about 10% of infants and 3% of the overall U.S. population. The disease can occur at any age, but is most common in infants and young adults. The condition usually improves in childhood or sometime before the age of 25.
In infancy, atopic dermatitis is evidenced by an itching, oozing, and crusting condition that tends to occur mainly on the face and scalp. If the disease continues or occurs beyond infancy, the skin has less of a tendency to be red, blistering, oozing, and crusting. Instead, the lesions become dry, red to brown, and the skin may become scaly and thickened. An intense, almost unbearable itching can continue. Some patients scratch at their skin until it bleeds and crusts, which can lead to infection.
Seborrheic dermatitis is another type of eczema. It consists of a red, scaly, itchy rash in the areas of the body with the highest concentration of sebaceous glands. These include the navel, breasts, underarms, groin, and buttocks.
Psoriasis is a persistent skin disease in which the skin becomes inflamed, producing red, thickened areas with silvery scales, most often on the scalp, elbows, knees, and lower back. The FDA refers to psoriasis as a condition of the scalp or body characterized by irritation, itching, redness, and extreme excess shedding of dead epidermal cells. 21 C.F.R. Chapter 1, Section 358.703 (c). Psoriasis can be so mild that people do not know they have it, or it can be quite severe. The most common form begins with little red bumps that gradually grow larger and form scales. While the top scales flake off easily and often, scales below the surface stick together. When they are removed, the tender, exposed skin bleeds. These small red areas then grow, sometimes becoming quite large. Evidence suggest psoriasis may be caused by malfunctioning white blood cells, causing inflammation in the skin. The cells of the skin then divide too rapidly, causing the skin to shed itself every three to four days. Psoriasis afflicts 2% of the U.S. population and costs the nation between $2 billion and $3 billion each year.
FDA regulations (e.g., 21 C.F.R. Chapter 1, Section 358, Subpart H-Drug Products for the Control of Dandruff, Seborreic Dermatitis and Psoriasis; 21 C.F.R. Ch. 1, Section 348xe2x80x94External Analgesic Drug Products for Over-The-Counter Human Use, Feb. 8, 1983; and 21 C.F.R. Ch. 1, Section 348xe2x80x94External Analgesic Drug Products for Over-The-Counter Human Use, Feb. 27, 1990) regulate what components (i.e., xe2x80x9cactive ingredientsxe2x80x9d), in a specified amount, may be described as providing relief or controlling the symptoms of psoriasis, seborrheic dermatitis, or eczema (i.e., contains a topical psoriasis drug, a topical dermatitis drug, or a topical eczema drug). In order to follow FDA regulations, as defined in the over-the-counter (OTC) monograph, only a select number of active ingredients that are able to provide relief or to control the symptoms of psoriasis, dermatitis, or eczema, in a specified amount, may be included in an appropriate dosage form which is described as capable of providing relief or controlling the symptoms of psoriasis, dermatitis, and/or eczema. Consequently, it is difficult to manufacture an adhesive patch that includes a topical psoriasis, dermatitis, or eczema drug, while at the same time (a) maintaining the solubility and stability of the active ingredients in the therapeutic formulation, (b) maintaining the pressure sensitive adhesive properties of the therapeutic formulation such that the patch can effectively exfoliate the skin upon removal, and (c) following FDA regulations.
Several adhesive patches, drug dispensing devices, electrodes, and bandages have been disclosed for applying salicylic acid and/or hydrocortisone to skin. See, e.g., U.S. Pat. Nos. 6,096,334; 6,096,033; 5,741,510; 5,536,263; 4,675,009; 4,307,717; and 4,274,420; which are all commonly assigned to Lec Tec Corporation (Minnetonka, Minn.).
U.S. Pat. No. 4,274,420 discloses an electrode for use in monitoring and stimulation medical applications. The electrode includes a connector plug and a skin-interfacing substrate material. The substrate material can include salicylic acid in 17.8 wt. % (see, Example 2). The reference, however, does not disclose or suggest that the electrode can be used to provide relief or to control the symptoms of psoriasis, seborrheic dermatitis, or eczema. In addition, the reference does not disclose or suggest that salicylic acid can be present in the amount permitted by the FDA (e.g., 1.8 wt. % to 3.0 wt. % of the substrate) to provide relief or to control the symptoms of psoriasis or seborrheic dermatitis. As such, the amount of salicylic acid disclosed therein does not comply with FDA regulations for controlling or treating the conditions of psoriasis or seborrheic dermatitis. See, e.g., 21 C.F.R. Ch. 1, Section 358.710 (b)(4), Apr. 1, 2000 Edition. Additionally, the backing is not disclosed as being treated with a sizing agent. As such, the overall yield of product can be higher, the xe2x80x9choldoutxe2x80x9d of therapeutic formulation on the backing can be improved, and the degree of penetration of the therapeutic formulation in the backing can be decreased. In addition, the nature and amount of adhesive in the therapeutic formulations that include salicylic acid may not be sufficient to exfoliate the skin, upon removal of the adhesive patch.
U.S. Pat. No. 4,307,717 discloses a bandage that includes a backing element and a substrate attached to the backing element. The substrate includes a matrix that includes a medicament. The medicament can be a keratolytic agent such as salicylic acid (see, col. 3, lines 41-44) or an anti-inflammatory agent such as hydrocortisone (see, col. 3, lines 31-33). However, the amount of salicylic acid or hydrocortisone that can be employed in the matrix or substrate is not disclosed. The reference does not disclose or suggest that the bandage can be used to provide relief or control the symptoms of psoriasis, seborrheic dermatitis, or eczema. In addition, the reference does not disclose or suggest that salicylic acid or hydrocortisone can be present in the amount permitted by the FDA (e.g., 1.8 wt. % to 3.0 wt. % of the substrate for salicylic acid and 0.25 wt. % to 1.0 wt. % of the substrate for hydrocortisone) to provide relief or to control the symptoms of psoriasis, seborrheic dermatitis, or eczema. As such, the amount of salicylic acid and hydrocortisone disclosed therein does not comply with FDA regulations for controlling or treating the conditions of psoriasis, seborrheic dermatitis, or eczema. See, e.g., 21 C.F.R. Ch. 1, Section 358.710 (b)(4), Apr. 1, 2000 Edition and 21 C.F.R. Ch. 1, Section 348.10 (d), Feb. 27, 1990. Additionally, the backing is not disclosed as being treated with a sizing agent. As such, the overall yield of product can be higher, the xe2x80x9choldoutxe2x80x9d of therapeutic formulation on the backing can be improved, and the degree of penetration of the therapeutic formulation in the backing can be decreased. In addition, the nature and amount of adhesive in the therapeutic formulations that include hydrocortisone may not be sufficient to exfoliate the skin, upon removal of the adhesive patch.
U.S. Pat. No. 4,675,009 discloses a drug dispensing device (e.g., an adhesive skin reservoir) for the transdermal delivery of a medicament. The drug dispensing device includes a backing element and a substrate attached to the backing element. The substrate includes a medicament wherein the medicament can be a keratolytic agent such as salicylic acid (see, col. 3, line 66) or a hormone such as hydrocortisone (see, col. 3, line 63). The salicylic acid can be present in 8-20% of the substrate (see, Example 20). The amount of hydrocortisone that can be employed in substrate is not disclosed. The reference does not disclose or suggest that the drug dispensing device can be used for controlling or treating the conditions of psoriasis, seborrheic dermatitis, or eczema. In addition, the reference does not disclose or suggest that salicylic acid or hydrocortisone can be present in the amount permitted by the FDA (e.g., 1.8 wt. % to 3.0 wt. % of the substrate for salicylic acid and 0.25 wt. % to 1.0 wt. % of the substrate for hydrocortisone) to control or treat the conditions of psoriasis, seborrheic dermatitis, or eczema. As such, the amount of salicylic acid and hydrocortisone disclosed therein does not comply with FDA regulations for controlling or treating the conditions of psoriasis, seborrheic dermatitis, or eczema. See, e.g., 21 C.F.R. Ch. 1, Section 358.710 (b)(4), Apr. 1, 2000 Edition and 21 C.F.R. Ch. 1, Section 348.10 (d), Feb. 27, 1990. Additionally, the backing is not disclosed as being treated with a sizing agent. As such, the overall yield of product can be higher, the xe2x80x9choldoutxe2x80x9d of therapeutic formulation on the backing can be improved, and the degree of penetration of the therapeutic formulation in the backing can be decreased. In addition, the nature and amount of adhesive in the therapeutic formulations that include hydrocortisone may not be sufficient to exfoliate the skin, upon removal of the adhesive patch.
U.S. Pat. Nos. 5,536,263 and 5,741,510 disclose an adhesive patch for applying medication to the skin. The patch includes a backing and a hydrocolloidal gel located on and in the backing. The gel includes a pressure-sensitive adhesive and a medicament. The medicament can be a keratolytic agent such as salicylic acid (see, U.S. Pat. No. 5,536,263; col. 5; lines 35-36 and U.S. Pat. No. 5,741,510; col. 5, line 35) or an anti-inflammatory agent such as hydrocortisone (see, U.S. Pat. No. 5,536,263; col. 5; lines 30-31 and U.S. Pat. No. 5,741,510; col. 5, lines 30-31). The salicylic acid can be present in 4.1 wt. % (see, U.S. Pat. No. 5,536,263 Example 46 or U.S. Pat. No. 5,741,510 Example 46). The hydrocortisone can be present in 1 wt. % or 0.5 wt. % of the gel (see, Examples 1, 3, 4, 5, 7, and 11 of U.S. Pat. No. 5,536,263 and Examples 1, 2, 3, 4, 5, 7, and 11 of U.S. Pat. No. 5,741,510). The reference does not disclose or suggest that the adhesive patch can be used for controlling or treating the conditions of psoriasis, seborrheic dermatitis, or eczema. In addition, the reference does not disclose or suggest that salicylic acid can be present in the amount permitted by the FDA (e.g., 1.8 wt. % to 3.0 wt. % of the substrate) to control or treat the conditions of psoriasis or seborrheic dermatitis. As such, the amount of salicylic acid disclosed therein does not comply with FDA regulations for controlling or treating the conditions of psoriasis or seborrheic dermatitis. See, e.g., 21 C.F.R. Ch. 1, Section 358.710 (b)(4), Apr. 1, 2000 Edition. The nature and amount of adhesive disclosed therein is not sufficient to exfoliate the skin, upon removal of the adhesive patch. Additionally, the backing is not disclosed as being treated with a sizing agent. As such, the overall yield of product can be higher, the xe2x80x9choldoutxe2x80x9d of therapeutic formulation on the backing can be improved, and the degree of penetration of the therapeutic formulation in the backing can be decreased. In addition, the nature and amount of adhesive in the therapeutic formulations that include hydrocortisone may not be sufficient to exfoliate the skin, upon removal of the adhesive patch.
U.S. Pat. Nos. 6,096,333 and 6,096,334 disclose adhesive patches for applying medication to the skin. The patch includes a backing layer and a hydrophilic pressure-sensitive adhesive reservoir that includes a medicament. The medicament can be a keratolytic agent such as salicylic acid (see, U.S. Pat. No. 6,096,333; col. 5; line 41 and U.S. Pat. No. 6,096,334; col. 5, line 41) or an anti-inflammatory agent such as hydrocortisone (see, U.S. Pat. No. 6,096,333; col. 5; lines 36-37 and U.S. Pat. No. 6,096,333; col. 5; lines 36-37). The salicylic acid can be present in 4.1 wt. % (see, U.S. Pat. No. 6,096,333 Example 46 and U.S. Pat. No. 6,096,333 Example 46). The hydrocortisone can be present in 1.0 wt. % or 0.5 wt. % (see, Examples 1, 2, 3, 4, 5, 7, 11 of U.S. Pat. No. 6,096,333 and Examples 1, 2, 3, 4, 5, 7, and 11 of U.S. Pat. No. 6,096,334). The references do not disclose or suggest that the adhesive patches can be used for controlling or treating the conditions of psoriasis, seborrheic dermatitis, or eczema. In addition, the reference does not disclose or suggest that salicylic acid can be present in the amount permitted by the FDA (e.g., 1.8 wt. % to 3.0 wt. % of the substrate). As such, the amount of salicylic acid disclosed therein does not comply with FDA regulations for controlling or treating the conditions of psoriasis or seborrheic dermatitis. See, e.g., 21 C.F.R. Ch. 1, Section 358.710 (b)(4), Apr. 1, 2000 Edition. The nature and amount of adhesive disclosed therein may not be sufficient to exfoliate the skin, upon removal of the adhesive patch. Additionally, the backing is not disclosed as being treated with a sizing agent. As such, the overall yield of product can be higher, the xe2x80x9choldoutxe2x80x9d of therapeutic formulation on the backing can be improved, and the degree of penetration of the therapeutic formulation in the backing can be decreased.
The adhesive patches, drug dispensing devices, electrodes, and bandages disclosed in, e.g., U.S. Pat. Nos. 6,096,334; 6,096,033; 5,741,510; 5,536,263; 4,675,009; 4,307,717; and 4,274,420 have experienced success in applying and/or delivering medication to the skin. There have been manufacturing difficulties, however, with these adhesive patches, drug dispensing devices, electrodes, and bandages. Specifically, it would be economically advantageous to increase the overall yield of these products in the manufacturing processes. It would also be economically beneficial to improve the xe2x80x9choldoutxe2x80x9d of the therapeutic formulations on the backings. Additionally, it would be economically advantageous to control the degree of penetration of the therapeutic formulations in the backings. Another difficulty with the adhesive patches, drug dispensing devices, electrodes, and bandages disclosed in, e.g., U.S. Pat. Nos. 6,096,334; 6,096,033; 5,741,510; 5,536,263; 4,675,009; 4,307,717; and 4,274,420 is that the nature and amount of adhesive or pressure sensitive adhesive present in the therapeutic formulation does not readily allow for the exfoliation of skin, upon removal of the adhesive patch, drug dispensing device, electrode, or bandage.
There is a need therefore for methods and devices for treating patients with psoriasis, seborrheic dermatitis, or eczema that have minimum adverse effects; have maximum efficacy; are simple and comfortable to use; administers to the skin an effective and current amount of a topical psoriasis, seborrheic dermatitis, or eczema drug; complies with FDA regulations; and/or exfoliates the skin upon removal of the device from the skin. The device will preferably have an overall yield of product that is higher than current devices, will preferably have an improved xe2x80x9choldoutxe2x80x9d of therapeutic formulation on the backing compared to current devices, and/or will have a lower degree of penetration of the therapeutic formulation in the backing of the device compared to known devices.
The present invention provides a water insoluble, protective, adhesive skin patch useful for treating or preventing psoriasis, dermatitis, and/or eczema. The adhesive skin patch administers to the skin an effective and known amount of a medicament (i.e., at least one of a topical psoriasis drug, a topical dermatitis drug, and a topical eczema drug). The adhesive skin patch maintains the adhesiveness of the adhesive and the stability of the medicament over a prolonged period of time typically experienced in the manufacturing, packaging, shipping, and/or the storage of the patch.
The medicament, solvent, and pressure sensitive adhesive are positioned on at least a portion of the adhesive patch, in at least a portion of the adhesive skin patch, or on and in at least a portion of the adhesive patch. Preferably, the medicament, solvent, and pressure sensitive adhesive are partially embedded in at least a portion of the adhesive skin patch. Additionally, the adhesive skin patch complies with FDA regulations (e.g., 21 C.F.R. Chapter 1, Subpart Hxe2x80x94Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis; 21 C.F.R. Ch. 1, Part 348xe2x80x94External Analgesic Drug Products for Over-The-Counter Human Use, Feb. 8, 1983; and 21 C.F.R. Ch. 1, Part 348xe2x80x94External Analgesic Drug Products for Over-The-Counter Human Use, Feb. 27, 1990).
The adhesive skin patch of the present invention can include a gel that is not water-based. The adhesive skin patch includes a backing that is treated with a sizing agent (e.g., a fluorocarbon solution, a silicone-containing compound, or a combination thereof). The sizing agent can be a hydrophobic sizing agent. The use of such backing prevents immediate wick through and maintains the hydrogel from penetrating the backing too quickly. In addition, the use of such backing provides an adhesive skin patch with a higher yield improvement and superior holdout properties. The use of such backing also obviates the need for a backing liner or a release liner. In such an embodiment, the adhesive skin patch can exist as a self wound adhesive patch.
The present invention provides an adhesive patch. The adhesive patch includes a flexible backing having a front side and a back side. A therapeutic formulation is positioned on at least a portion of the front side of the backing, in at least a portion of the front side of the backing, or on and in at least a portion of the front side of the backing. At least a portion of the backing is treated with a sizing agent such that the portion of the backing that is treated with the sizing agent has a surface energy of about 20 dynes/cm2 to about 65 dynes/cm2. The therapeutic formulation includes a medicament selected from one or more topical psoriasis drugs, one or more topical dermatitis drugs, one or more topical eczema drugs, or a combination thereof. The therapeutic formulation includes a solvent that dissolves the medicament and a pressure sensitive adhesive.
The present invention provides another adhesive patch. The adhesive patch includes a flexible backing having a front side and a back side. A therapeutic formulation is positioned on at least a portion of the front side of the backing, in at least a portion of the front side of the backing, or on and in at least a portion of the front side of the backing. At least a portion of the backing is treated with a sizing agent such that the portion of the backing that is treated with the sizing agent has a surface energy of about 20 dynes/cm2 to about 65 dynes/cm2. The sizing agent can be a hydrophobic sizing agent. The therapeutic formulation includes salicylic acid or a pharmaceutically acceptable salt thereof present in about 1.8 wt. % to about 3.0 wt. % of the therapeutic formulation, a solvent that dissolves the salicylic acid, and a pressure sensitive adhesive.
The present invention provides another adhesive patch. The adhesive patch includes a flexible backing having a front side and a back side. A therapeutic formulation is positioned on at least a portion of the front side of the backing, in at least a portion of the front side of the backing, or on and in at least a portion of the front side of the backing. At least a portion of the backing is treated with a sizing agent such that the portion of the backing that is treated with the sizing agent has a surface energy of about 20 dynes/cm2 to about 65 dynes/cm2. The sizing agent can be a hydrophobic sizing agent. The therapeutic formulation includes a medicament selected from one or more topical psoriasis drugs, one or more topical dermatitis drugs, one or more topical eczema drugs, or a combination thereof; and a hot melt adhesive.
The present invention provides another adhesive patch. The adhesive patch includes a flexible backing having a front side and a back side. A therapeutic formulation is positioned on at least a portion of the front side of the backing, in at least a portion of the front side of the backing, or on and in at least a portion of the front side of the backing. At least a portion of the backing is treated with a sizing agent such that the portion of the backing that is treated with the sizing agent has a surface energy of about 20 dynes/cm2 to about 65 dynes/cm2. The sizing agent can be a hydrophobic sizing agent. The therapeutic formulation includes a corticosteroid; a cyclodextrin or a derivative of cyclodextrin that effectively solubilizes the corticosteroid; and a pressure sensitive adhesive.
The therapeutic formulation can be partially embedded in at least a portion of the front side of the backing. The therapeutic formulation can be located on the entire surface of the front side of the backing. The backing can be porous. The backing can be vapor permeable. The backing can include water insoluble material. The backing can have a thickness of about 0.025 mm to about 1.25 mm. The backing can include a nonwoven fabric.
The hydrophobic sizing agent can be a fluorocarbon solution, a Silicone-containing compound, or a combination thereof. The backing that is treated with the fluorocarbon solution can be VILMED(trademark) M1585 W/HY, VILMED(trademark) M1585H/HY, VILMED(trademark) M1586 W/HY, VILMED(trademark) M1586 H/HY, VILMED(trademark) M1570, VILMED(trademark) M1573 F, VILMED(trademark) M1573 FH, VILMED(trademark) M1577 F, VILMED(trademark) M1578 F, VILMED(trademark) M1578 FH, or a combination thereof. The silicone-containing compound can be a polydimethyl siloxane, a dialkylsiloxane, a dimethylsiloxo vinyl alkene, a dialkylsiloxo vinyl alkene, a dimethylsiloxo acrylate, a dialkylsiloxo acrylate, a vinyl terminated polydimethylsiloxane, a vinyl terminated polydialkylsiloxane, or a combination thereof.
The entire front side of the backing can be treated with the sizing agent. The sizing agent can penetrate at least a portion of the underlying surface of the front side of the backing. The sizing agent can be a hydrophobic sizing agent. The sizing agent can penetrate the entire underlying surface of the front side of the backing. The entire backing can be treated with the sizing agent. The backing can include polycellulose fibers, polyester fibers, polyurethane fibers, polyolefin fibers, polyamide fibers, cotton fibers, copolyester fibers, or any mixture thereof. The backing, upon contact with skin, can retain the therapeutic formulation and allow moisture from the skin to pass.
The topical psoriasis drug or the topical dermatitis drug can be coal tar, pyrithione zinc, salicylic acid, selenium sulfide, a pharmaceutically acceptable salt thereof, or any combination thereof. The topical psoriasis drug or the topical dermatitis drug can be salicylic acid, or a pharmaceutically acceptable salt thereof. The salicylic acid, or the pharmaceutically acceptable salt thereof, can be present in about 0.5 wt. % to about 5.0 wt. % of the therapeutic formulation. The salicylic acid, or the pharmaceutically acceptable salt thereof, can be present in about 1.8 wt. % to about 3.0 wt. % of the therapeutic formulation.
The topical eczema drug can be camphor, menthol, benzocaine, butamben picrate, dibucaine, dibucaine hydrochloride, dimethisoquin hydrochloride, dyclonine hydrochloride, lidocaine, lidocaine hydrochloride, pramoxine hydrochloride, tetracaine, tetracaine hydrochloride, benzyl alcohol, camphorated metacresol, juniper tar, phenol, phenolate sodium, resorcinol, diphenhydramine hydrochloride, tripelennamine hydrochloride, hydrocortisone, hydrocortisone acetate, or a combination thereof. Specifically, the topical eczema drug can be hydrocortisone, hydrocortisone acetate, or a combination thereof, or the topical eczema drug can be lidocaine, lidocaine hydrochloride, or a combination thereof.
The camphor can be present up to about 3.0 wt. % of the therapeutic formulation and menthol can be present up to about 1.0 wt. % of the therapeutic formulation; benzocaine can be present in about 5.0 wt. % to about 20.0 wt. % of the therapeutic formulation; butamben picrate can be present in about 0.5 wt. % to about 1.5 wt. % of the therapeutic formulation; dibucaine can be present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation; dibucaine hydrochloride can be present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation; dimethisoquin hydrochloride can be present in about 0.3 wt. % to about 0.5 wt. % of the therapeutic formulation; dyclonine hydrochloride can be present in about 0.5 wt. % to about 1.0 wt. % of the therapeutic formulation; lidocaine can be present in about 0.5 wt. % to about 4.0 wt. % of the therapeutic formulation; lidocaine hydrochloride can be present in about 0.5 wt. % to about 4.0 wt. % of the therapeutic formulation; pramoxine hydrochloride can be present in about 0.5 wt. % to about 1.0 wt. % of the therapeutic formulation; tetracaine can be present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation; tetracaine hydrochloride can be present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation; benzyl alcohol can be present in about 10.0 wt. % to about 33.0 wt. % of the therapeutic formulation; camphor can be present in about 0.1 wt. % to about 3.0 wt. % of the therapeutic formulation; juniper tar can be present in about 1.0 wt. % to about 5.0 wt. % of the therapeutic formulation; phenolate sodium can be present in about 0.5 wt. % to about 1.5 wt. % of the therapeutic formulation; resorcinol can be present in about 0.5 wt. % to about 3.0 wt. % of the therapeutic formulation; diphenhydramine hydrochloride can be present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation; tripelennamine hydrochloride can be present in about 0.5 wt. % to about 2.0 wt. % of the therapeutic formulation; hydrocortisone can be present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation; corticosteroid can be present in about 0.25 to about 5.0 wt. % of the therapeutic formulation; camphor can be present in about 3 wt. % to about 10.8 wt. % of the therapeutic formulation with phenol; camphor can be present in about 3 wt. % to about 10.8 wt. % of the therapeutic formulation with metacresol present in about 1 wt. % to about 3.6 wt. % of the therapeutic formulation, as camphorated metacresol; or hydrocortisone acetate can be present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation.
The medicament (i.e., the topical psoriasis drug, the topical dermatitis drug, the topical eczema drug, or a combination thereof) can be a corticosteroid. The corticosteroid can be at least one of cortisol (hydrocortisone); tetrahydrocortisol; prednisone (cortisone); prednisolone (cortisol); 6xcex1-methylprednisolone; fludrocortisone (9xcex1-fluorocortisol); 11-desoxycortisol; cortisone (11-dehydrocortisol); corticosterone; triamcinolone (9xcex1-fluoro-16xcex1-hydroxyprednisolone); paramethasone (6xcex1-fluoro-16xcex1-methylprednisolone); betamethasone (9xcex1-fluoro-16xcex2-methylprednisolone); dexamethasone (9xcex1-fluoro-16xcex1-methylprednisolone); desoxycorticosterone acetate (doca acetate, percorten acetate); desoxycorticosterone pivalate (percorten pivalate); fludrocortisone acetate (florine acetate); cortisol (hydrocortisone) (cortef, hydrocortone); cortisol acetate (cortef acetate, hydrocortone acetate); cortisol cypionate (cortef); cortisol sodium phosphate (hydrocortone phosphate); cortisol sodium succinate (solu-cortef); beclopmethasone dipropionate (vanceril); betamethasone (celestone); betamethasone sodium phosphate and acetate (celestone soluspan); betamethasone dipropionate (diprosone); betamethasone valerate (valisone); betamethasone benzoate (benisone, flurodate); cortisone acetate (cortone acetate); dexamethasone (decadron, gammacorten); dexamethasone sodium phosphate (decadron phosphate, hexadrol phosphate); dexamethasone acetate (decadron-L.A.); fuprednisolone (alphadrol); meprednisone (betapar); methylprednisolone (medrol); methylprednisolone acetate (depo-medrol, medrol acetate); methylprednisolone sodium succinate (solu-medrol); paramethasone acetate (haldrone); prednisolone (delta-cortef); prednisolone acetate (meticortelone acetate); prednisolone sodium phosphate (hydeltrasol); prednisolone sodium succinate (meticortelone soluble); prednisolone tebutate (hydelta-T.B.A.); prednisone (deltasone, paracort); triamcinolone (aristocort, kenacort); triamcinolone acetonide (aristoderm, kenalog); triamcinolone diacetate (aristocort diacetate, kienacort diacetate); triamcinolone hexacotonide (aristospan); desonide (tridesilon); desoximetasone (topicort); flumethasone pivalate (locorten); fluocinolone acetonide (fluonid, synalar); fluocinonide (lidex, topsyn); fluorometholone (oxylone); flurandrenolide (cordran); halcinonide (halog); medrysone (HMS liquifilm, medrocort); aclometasone dipropionate (alclovate); betamethasone-17-benzoate (benisone, flurobate); betamethasone dipropionate (diprosone); betamethasone-17-valerate (valisone); clobetasol propionate (temovate); desonide (desowen, tridesilon); dexamethasone (aeroseb-D); desoximetasone (topicort); diflorasone diacetate (florone); flumethasone pivalate (locorten); fluocinolone acetonide (synalar, synalar-HP, neosynalar, fluonid); fluocinolone acetonide acetate (lidex; lidex-E; topsyn); fluorometholone (oxylone); flurandrenolide (cordran); halcinonide (halog); hydrocortisone (cort-dome, lubricort); hydrocortisone acetate (cortef, carmol HC, neo-cortef); hydrocortisone-17-valerate (westcort); prednisolone (meti-derm); triamcinolone acetonide (kenalog, orabase, kenalog-S, mycolog, aristocort, aristocort-A, aristoderm, neo-aristoderm, neo-aristocort); temovate; diprolen; psorcon; temovate; diprolene; cyclocort; diprosone; florone; halog; lidex; maxiflor; topicort; aristocort A; diprosone; florone; maxiflor; valisone; cordran; kenalog; synalar; topicort LP; westcort; cordran; diprosone; kenalog; locold; synalar; valisone; westcort; aclovate; desowen; locorten; synalar; tridesilone; valisone; hydrocortisone; dexamethasone; flumethalone; prednisolone; methylprednisolone; augmented betamethasone dipropionate (diprolene); diflorasone diacetate (psorcon); clobetasol propionate (temovate); halobetasol propionate (ultravate); amcinonide (cyclocort); betamethasone dipropionate (diprolene, diprosone); diflorasone diacetate (florone); halcinonide (halog); fluocinonide (lidex); diflorasone diacetate (maxiflor); betamethasone dipropionate (maxivate); diflorasone diacetate (psorcom); desoximetasone (topicort); (aristocort A); amcinonide (cyclocort); betamethasone dipropionate (diprosone); mometasone furoate (elocon); diflorasone diacetate (florone); halcinonide (halog); fluocinonide (lidex-E); diflorasone diacetate (maxiflor); betamethasone dipropionate (maxivate, psorion); betamethasone valerate (valisone); flurandrenolide (cordran); fluticasone propionate (cutivate); mometasone furoate (elocon); triamcinolone acetonide (kenalog); fluocinolone acetonide (synalar); hydrocortisone valerate (westcort); flurandrenolide (cordran); fluticasone propionate (cutivate); betamethasone dipropionate (diprosone); triamcinolone acetonide (kenalog); hydrocortisone butyrate (locoid); fluocinolone acetonide (synalar); betamethasone valerate (valisone); hydrocortisone valerate (westcort); alclometasone dipropionate (aclovate); triamcinolone acetonide (aristocort); desonide (desowen); flumethasone pivalate (locorten); fluocinolone acetonide (synalar); desonide (tridesilon); betamethasone valerate (valisone); hydrocortisone (eldecort, dexamethasone, flumethalone, hydrocortisone, methylprednisolone, or prednisolone); betamethasone; and dexamethasone. The corticosteroid can be present up to about 5 wt. % of the therapeutic formulation.
The therapeutic formulation can include a complexing agent that effectively solubilizes or stabilizes the medicament. The complexing agent can be a cyclodextrin, or a derivative of cyclodextrin. The cyclodextrin or the derivative of cyclodextrin can be alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin, alpha-cyclodextrin sulfate, beta-cyclodextrin sulfate, gamma-cyclodextrin sulfate, alpha-hydroxypropyl cyclodextrin, beta-hydroxypropyl cyclodextrin, gamma-hydroxypropyl cyclodextrin, alpha-cyclodextrin phosphate, beta-cyclodextrin phosphate, or gamma-cyclodextrin phosphate.
The solvent can include a polyhydric alcohol, water, or a combination thereof. The polyhydric alcohol can be propylene glycol, ethylene glycol, triethylene glycol, or a combination thereof. Alternatively, the solvent can include water; triethylene glycol; glycerin; propylene glycol; triacetin; 1,3-propane diol; 2-methyl-1,3-propane diol; glycerol ricinoleate; PEG-6 caprylic/capric glycerides; caprylic/capric triglycerides; propyleneglycol dicaprylate/dicaprate; glycerol monostearate; glycerol monocaprylate; glycerol monolaurate; neopentyl alcohol; 1-hexadecanol; hydroxypropyl beta-cyclodextrin; vitamin E; vitamin E acetate; deoxycholic acid; taurodeoxycholic acid; 3-[(3-cholamidopropyl)dimethylammonio]-1-propane-sulfonate; BigCHAP; cholic acid; cholesterol NF; propylene carbonate; lecithin; a pharmaceutically acceptable salt thereof; or a combination thereof. The solvent can be present in about 3.0 wt % to about 25.0 wt. % of the therapeutic formulation. Specifically, the propylene glycol can be present in about 3.0 wt. % to about 30.0 wt. % of the therapeutic formulation; the water can be present in about 2.0 wt. % to about 20.0 wt. % of the therapeutic formulation; and/or the triethylene glycol can be present in about 2.0 wt. % to about 30.0 wt. % of the therapeutic formulation. More specifically, the propylene glycol can be present in about 3.0 wt. % to about 11.0 wt. % of the therapeutic formulation; the water can be present in about 2.0 wt. % to about 20.0 wt. % of the therapeutic formulation; and/or the triethylene glycol can be present in about 2.0 wt. % to about 20.0 wt. % of the therapeutic formulation.
The therapeutic formulation can further include a filler. The filler can be malto dextrin. The malto dextrin can be present in about 1.0 wt. % to about 10.0 wt. % of the therapeutic formulation.
The pressure sensitive adhesive can include one or more acrylic ester copolymers. Each of the one or more acrylic ester copolymers can be present up to about 20.0 wt. % of the therapeutic formulation. All of the one or more acrylic ester copolymers, combined, can be present in about 5.0 wt. % to about 30.0 wt. % of the therapeutic formulation. The pressure sensitive adhesive can be located on the entire portion of surface of the front side of the backing. The pressure sensitive adhesive can be at least partially embedded in the front side of the backing. The pressure sensitive adhesive can be completely embedded in the backing.
The pressure sensitive adhesive can further include glycerin. The glycerin can be present in about 25.0 wt. % to about 70.0 wt. % of the therapeutic formulation. The glycerin can be present in about 40.0 wt. % to about 55.0 wt. % of the therapeutic formulation.
The pressure sensitive adhesive can include an emulsifier. The emulsifier can be pectin. The pectin can be present in about 2.0 wt. % to about 10.0 wt. % of the therapeutic formulation.
The pressure sensitive adhesive can include one or more compounds that provide structure and strength to the pressure sensitive adhesive or provide structure and strength to the therapeutic formulation. The compound that provides structure and strength to the pressure sensitive adhesive or provide structure and strength to the therapeutic formulation can be karaya, a polyacrylamide, xanthum gum, guar gum, a natural polymer, a synthetic polymer, a hydrophilic polymer, a hydrocolloidal polymer, starch, a starch derivative, vinyl acetate copolymer, polyvinyl pyrrolidone, polyethylene oxide, algin, derivatives of algin, a polyacrylate, polymaleic acid, polymaleic anhydride, a polyurethane, a polyurea, gum acacia, locust bean gum, modified guar gum, maltodextrin, carboxymethyl cellulose, carboxypropyl cellulose, polyvinyl alcohol, poly AMPS or a mixture thereof. The compound that provides structure and strength to the pressure sensitive adhesive or provide structure and strength to the therapeutic formulation can be polyacrylamide. The compound that provides structure and strength to the pressure sensitive adhesive or provide structure and strength to the therapeutic formulation can be karaya. The compound that provides structure and strength to the pressure sensitive adhesive or provide structure and strength to the therapeutic formulation can be a combination of polyacrylamide and karaya. The polyacrylamide can be present in about 8.0 wt. % to about 30.0 wt. % of the therapeutic formulation. The karaya can be present in about 8.0 wt. % to about 40.0 wt. % of the therapeutic formulation.
The therapeutic formulation can further include one or more skin conditioners. The skin conditioner can be calamine, aloe, lanolin, glycerin, Vitamin E, Vitamin E acetate, farnesol, glycyrrhetinic acid, or a combination thereof. The aloe can be present up to about 2.0 wt. % of the therapeutic formulation. The Vitamin E acetate can be present up to about 2.0 wt. % of the therapeutic formulation.
The therapeutic formulation can further include one or more antimicrobial agents. The antimicrobial agent can be a xcex2-lactam compound, an aminoglycoside, or an antifungal agent. The antimicrobial agent can be erythromycin, tetracycline, clindamycin, or cephalosporin. The therapeutic formulation can further include an antiseptic agent. The antiseptic agent can be triclosan, phenoxy isopropanol, chlorhexidine gluconate, povidone iodine, or any combination thereof.
The therapeutic formulation can further include one or more preservatives. The preservative can be quat 15, methyl paraben, ascorbic acid, or a combination thereof. The preservative can be present up to about 10.0 wt. % of the therapeutic formulation.
The adhesive patch can have a thickness of about 0.20 mm to about 0.75 mm. The adhesive patch can further include a release liner that is mounted on the front side of the backing. More than one patch can be mounted on the release liner. For example, about 2 to about 20 adhesive patches can be mounted on the release liner. The adhesive patch can be crescent, circular, or oval. The circular adhesive patch can have a diameter of about 0.1 inch to about 1.0 inch.
The present invention also provides a method for treating or preventing at least one of psoriasis, dermatitis, and eczema in a mammal (e.g., human). The method includes applying to the skin surface of the mammal having the psoriasis, dermatitis, and/or eczema, or the skin surface of the mammal at risk thereof an adhesive patch of the present invention for a period of time effective to treat or prevent psoriasis, dermatitis, and/or eczema. The skin surface of the mammal having the psoriasis, dermatitis, and/or eczema or the skin surface of the mammal at risk thereof can include the head, face, scalp, neck, shoulder, chest, back, arm, hand, leg, foot, navel, breast, underarm, groin, buttock, elbow, knee, eyelid, outer surface of the ear, gluteal fold, or any combination thereof. The period of time that the adhesive patch is applied to the skin surface can be about one hour to about 12 hours.
The present invention also provides a method for exfoliating the skin surface of a mammal (e.g., human). The method includes applying to the skin surface of the mammal in need of such exfoliation an adhesive patch of the present invention and removing the adhesive patch, thereby effectively exfoliating the skin surface. The adhesive patch can be applied to the skin surface of the mammal for about one second to about 12 hours. In addition, the skin surface in need of such exfoliation can include the head, face, scalp, neck, shoulder, chest, back, arm, hand, leg, foot, navel, breast, underarm, groin, buttock, elbow, knee, eyelid, outer surface of the ear, gluteal fold, or any combination thereof.